Health BehaviorNCT03450382
Hans Kai: Impact of a Peer Lead Community Health Program on Behavior Change, Mental Health, Health Efficacy and Social Support Comparative Control Study
A study testing Hans Kai Education in people with Health Behavior, run by NorWest Co-op Community Health at 1 site in Canada.
Trial summary
To study the difference between participants interested in a lifestyle change when enrolled in Hans Kai or not when comparing behaviour change, social support, self health efficacy and mental health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Hans Kai Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- cognitively impaired
- Under 18
- students of children of Research team
- clients in emergency/life threatening conditions
Trial locations and contacts
1 site in 1 country.
About this study
To study the difference between participants interested in a lifestyle change when enrolled in Hans Kai or not when comparing behaviour change, social support, self health efficacy and mental health. Hans Kai is a community based, peer led program that is low cost and self sustaining, which places participants through a 9 week health school to learn skills related to improving health such as nutrition, exercise, sleep, stress management etc. Once completed, participants form a Hans Kai group and continue meeting independently of health care providers
Read the detailed description
Research Question Does Hans Kai have a greater influence on healthy behavior change, mental health status, social connectedness, and self-health efficacy outcomes compared to community healthcare clients with access to health education programming.
Hypothesis - Hans Kai members will experience higher mental health improvement scores compared to control group.
Hans Kai members will experience greater social connectedness compared to control group.
Hans Kai members will experience greater self-health efficacy compared to control group.
Hans Kai members will adopt more behavior changes compared to control group.
Null Hypothesis - There is no significant difference between Hans Kai members and control group in terms of mental health improvement scores.
There is no significant difference between Hans Kai members and control group in terms of social connectedness scores.
There is no significant difference between Hans Kai members and control group in terms of self-health efficacy scores.
There is no significant difference between Hans Kai members and control group in terms of adopted behavior change numbers.
In order to meet the demand for health programming in and reduce the prevalence of chronic disease NorWest developed the HANS KAI Project. Hans Kai is a self-sustaining, participant led health program for individuals wanting to maintain or improve their health. Hans Kai groups consist of 8-40 people per group in communities or workplaces. Hans Kai empowers individuals to take control of their own health and provides a unique opportunity for participants to have an active role in improving or maintaining their own health and well-being and that of their community.
HANS Kai Focuses on a number of factors relating to health including:
Healthy eating, physical activity, managing sleep and stress, mental health, physical health indicators, leadership and social supports. The program is participant led which enables members to have an active role in their health and the health of their families and communities.
Currently NorWest has trained 37 people in 5 provinces across Canada to deliver HANS KAI in their community and demand is growing. NorWest has developed a Teen and Family HANS KAI to address health across the ages.
HANS KAI's initial research phase assessed roughly 60 participants over 2 years to determine the impact of Hans Kai on strategic health indictors and influences. Our research and evaluation showed statistically significant improvements in:
Mental Health (prior to HANS Kai 33% had Flourishing Mental Health at 12 months 69% had Flourishing Mental Health) Physical Activity Knowledge of Health Connection to Resources Increased Social Connections, and Upward trends in nutrition. As the program continued to evolve, community members and participants were involved in every phase, giving community feedback on important health related topics they wanted discussed and to be given more information on. This lead the researchers toward the second phase of research which now focuses heavily on behavior change. Putting into practice the information that participants learn was the highest feedback received, and this echoes trends in health promotion interventions, as preventative healthcare and integrated service becomes the pinnacle to healthy communities. Empowering people and building their resilience is dependent on needs and perceived value of different lifestyle influences. For instance, an economically disadvantaged family may struggle on a low income, but may find value in the Hans Kai nutrition classes on how to feed their family healthy options and recipes on a fixed budget. Addressing a change from eating take-out to home cooking helps to move this family towards better health and become economically stronger through education and application. Building on this scenario, Hans Kai also serves to bolster social engagement, drawing out isolated individuals to engage in their communities, increasing their mental health and well-being. The researchers strive to prove that this support carries over into the overall lifestyle, increasing the likelihood and motivation to improve physical activity levels with other group members interested in the same. This increase in self-efficacy promotes community and family leadership, as others see positive life choices, they are likely to join in, seeing family walks become routine and volunteering in community engagement on the rise.
The researchers are wanting to prove that community led health programs lead to health behaviour changes in healthy lifestyle choices with social support and self-efficacy.
After completing our first phase of research, the researchers were able to determine challenges and how to improve them as research heads into the second phase. Creating group champions to help collect interval research data and modifying our research to determine a power difference between a control and Hans Kai member was of the utmost importance. The research objectives will be looking to discover the differences between non Hans Kai community members and Hans Kai members in the areas of: self-efficacy, behavior change, physical activity, nutrition, mental health and community connectedness. Data comparisons from initial baselines without the Hans Kai intervention, followed by a 9 week survey after Hans Kai participants have completed the health school, followed by a 6 month and one year survey will be assessed. The purpose in completing these objectives is to determine whether the Hans Kai model produces better results in each of the mentioned areas for participants interested in a lifestyle change compared to those participants not introduced to the Hans Kai concept of education. If successful, the Hans Kai model will be further studied and promoted to more community health clinics as a low cost method to produce positive healthy behaviours to communities.
- Conditions
- Health Behavior
- Being tested
- Hans Kai Education
- Keywords
- community health, mental health, behavior change, social support, health promotion
- Medical subject headings
- Health Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hans Kai EducationOther
9 weeks of health education classes preceding social group formation into Hans Kai. Peer led support focused on behavioural change.
| Study group | Role | What they receive |
|---|---|---|
| Hans Kai Participant | Experimental | Participants receiving Hans Kai intervention Receives: Other: Hans Kai Education |
| Control | No intervention | Participants not enrolled in Hans Kai |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviour Change
To determine the power difference between Hans Kai participants and control group with respect to behavior change. Readiness to Change, Confidence to Change Questionnaire: Gillespie \& Lenz (2011) will be used to measure this outcome.
Measured: 1 year
Self-health Efficacy
To determine the power difference between Hans Kai participants and control group with respect to self-health efficacy. Health Self-Efficacy Questionnaire: Lee, Hwang, Hawkins \& Pingree (2008) will be used to measure this outcome.
Measured: 1 year
Social Support
To determine the power difference between Hans Kai participants and control group with respect to Social Support. A Social Connectedness Questionnaire developed by researchers will be used to measure this outcome.
Measured: 1 year
Mental Health
To determine the power difference between Hans Kai participants and control group with respect to mental health. Mental Health Questionnaire: Keyes, C.L.M. (2009) will be used to measure this outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Why it stopped: New Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Open label, quasi-experimental clinical trial comparative study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NorWest Co-op Community Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike Sadlowski, NorWest Co-op Community Health
- Investigators
- Leanne LeClair, PHD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450382
- Sponsor's protocol ID
- 02222018
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hans Kai: Impact of a Peer Lead Community Health Program on Behavior Change, Mental Health, Health Efficacy and Social Support Comparative Control Study
- ClinicalTrials.gov ID
- NCT03450382
- Acronym / sponsor ID
- 02222018
- Conditions
- Health Behavior
- Keywords
- community health, mental health, behavior change, social support, health promotion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New Principal Investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NorWest Co-op Community HealthUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the difference between participants interested in a lifestyle change when enrolled in Hans Kai or not when comparing behaviour change, social support, self health efficacy and mental health. Hans Kai is a community based, peer led program that is low cost and self sustaining, which places participants through a 9 week health school to learn skills related to improving health such as nutrition, exercise, sleep, stress management etc. Once completed, participants form a Hans Kai group and continue meeting independently of health care providers
Detailed description
Research Question Does Hans Kai have a greater influence on healthy behavior change, mental health status, social connectedness, and self-health efficacy outcomes compared to community healthcare clients with access to health education programming.
Hypothesis - Hans Kai members will experience higher mental health improvement scores compared to control group.
Hans Kai members will experience greater social connectedness compared to control group.
Hans Kai members will experience greater self-health efficacy compared to control group.
Hans Kai members will adopt more behavior changes compared to control group.
Null Hypothesis - There is no significant difference between Hans Kai members and control group in terms of mental health improvement scores.
There is no significant difference between Hans Kai members and control group in terms of social connectedness scores.
There is no significant difference between Hans Kai members and control group in terms of self-health efficacy scores.
There is no significant difference between Hans Kai members and control group in terms of adopted behavior change numbers.
In order to meet the demand for health programming in and reduce the prevalence of chronic disease NorWest developed the HANS KAI Project. Hans Kai is a self-sustaining, participant led health program for individuals wanting to maintain or improve their health. Hans Kai groups consist of 8-40 people per group in communities or workplaces. Hans Kai empowers individuals to take control of their own health and provides a unique opportunity for participants to have an active role in improving or maintaining their own health and well-being and that of their community.
HANS Kai Focuses on a number of factors relating to health including:
Healthy eating, physical activity, managing sleep and stress, mental health, physical health indicators, leadership and social supports. The program is participant led which enables members to have an active role in their health and the health of their families and communities.
Currently NorWest has trained 37 people in 5 provinces across Canada to deliver HANS KAI in their community and demand is growing. NorWest has developed a Teen and Family HANS KAI to address health across the ages.
HANS KAI's initial research phase assessed roughly 60 participants over 2 years to determine the impact of Hans Kai on strategic health indictors and influences. Our research and evaluation showed statistically significant improvements in:
Mental Health (prior to HANS Kai 33% had Flourishing Mental Health at 12 months 69% had Flourishing Mental Health) Physical Activity Knowledge of Health Connection to Resources Increased Social Connections, and Upward trends in nutrition. As the program continued to evolve, community members and participants were involved in every phase, giving community feedback on important health related topics they wanted discussed and to be given more information on. This lead the researchers toward the second phase of research which now focuses heavily on behavior change. Putting into practice the information that participants learn was the highest feedback received, and this echoes trends in health promotion interventions, as preventative healthcare and integrated service becomes the pinnacle to healthy communities. Empowering people and building their resilience is dependent on needs and perceived value of different lifestyle influences. For instance, an economically disadvantaged family may struggle on a low income, but may find value in the Hans Kai nutrition classes on how to feed their family healthy options and recipes on a fixed budget. Addressing a change from eating take-out to home cooking helps to move this family towards better health and become economically stronger through education and application. Building on this scenario, Hans Kai also serves to bolster social engagement, drawing out isolated individuals to engage in their communities, increasing their mental health and well-being. The researchers strive to prove that this support carries over into the overall lifestyle, increasing the likelihood and motivation to improve physical activity levels with other group members interested in the same. This increase in self-efficacy promotes community and family leadership, as others see positive life choices, they are likely to join in, seeing family walks become routine and volunteering in community engagement on the rise.
The researchers are wanting to prove that community led health programs lead to health behaviour changes in healthy lifestyle choices with social support and self-efficacy.
After completing our first phase of research, the researchers were able to determine challenges and how to improve them as research heads into the second phase. Creating group champions to help collect interval research data and modifying our research to determine a power difference between a control and Hans Kai member was of the utmost importance. The research objectives will be looking to discover the differences between non Hans Kai community members and Hans Kai members in the areas of: self-efficacy, behavior change, physical activity, nutrition, mental health and community connectedness. Data comparisons from initial baselines without the Hans Kai intervention, followed by a 9 week survey after Hans Kai participants have completed the health school, followed by a 6 month and one year survey will be assessed. The purpose in completing these objectives is to determine whether the Hans Kai model produces better results in each of the mentioned areas for participants interested in a lifestyle change compared to those participants not introduced to the Hans Kai concept of education. If successful, the Hans Kai model will be further studied and promoted to more community health clinics as a low cost method to produce positive healthy behaviours to communities.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, quasi-experimental clinical trial comparative study.
| Arm | Type | Receives |
|---|---|---|
| Hans Kai Participant | Experimental | Other: Hans Kai EducationParticipants receiving Hans Kai intervention |
| Control | No intervention | –Participants not enrolled in Hans Kai |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- cognitively impaired
- Under 18
- students of children of Research team
- clients in emergency/life threatening conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hans Kai Education9 weeks of health education classes preceding social group formation into Hans Kai. Peer led support focused on behavioural change. | Other | Hans Kai Participant |
Primary outcome
Behaviour Change
Time frame: 1 year
To determine the power difference between Hans Kai participants and control group with respect to behavior change. Readiness to Change, Confidence to Change Questionnaire: Gillespie \& Lenz (2011) will be used to measure this outcome.
Self-health Efficacy
Time frame: 1 year
To determine the power difference between Hans Kai participants and control group with respect to self-health efficacy. Health Self-Efficacy Questionnaire: Lee, Hwang, Hawkins \& Pingree (2008) will be used to measure this outcome.
Social Support
Time frame: 1 year
To determine the power difference between Hans Kai participants and control group with respect to Social Support. A Social Connectedness Questionnaire developed by researchers will be used to measure this outcome.
Mental Health
Time frame: 1 year
To determine the power difference between Hans Kai participants and control group with respect to mental health. Mental Health Questionnaire: Keyes, C.L.M. (2009) will be used to measure this outcome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne LeClair, PHD study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hans Kai Education in people with Health Behavior, run by NorWest Co-op Community Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviour Change (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.